- Aequor (Thousand Oaks, CA)
- …Sr. Associate Quality Assurance position supports 's Quality Assurance program under the Plant QA organization providing daily oversight of the Drug ... on the manufacturing floor, inc. Inspection support, ASP and QA assessments, Electronic batch record review, SOP revision approval,...functional area quality for the Drug Product Quality Assurance department in the execution of… more
- Catalent (San Diego, CA)
- …Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance ( QA ) at our Clinical Supplies facility. As a member ... all Performance Management Program (PMP) actions for the site Quality Assurance department. This includes professional development... quality issues to Site Leadership Team and QA senior management.Lead programs for: QA… more
- Aequor (Thousand Oaks, CA)
- …are supporting Rotate every 6 months This position supports 's Quality Assurance program under the Plant QA organization providing daily oversight of the ... Associate will also represent functional area for the Drug Substance Quality Assurance department in the execution of projects necessary to achieve departmental… more
- Catalent (St. Petersburg, FL)
- I. Department Overview: The Quality Assurance Department is responsible for providing leadership and support to the Catalent St. Petersburg site. The Department ... of process controls in all applicable areas of the manufacturing operation. The Senior QA Specialist will assist in organizing and prioritizing the activities… more
- Insmed Incorporated (Bridgewater, NJ)
- …to the Executive Director of Development Quality Assurance , the Senior Director of Pharmacovigilance QA serves as a strategic partner managing ... to, the following:Facilitate and maintain a risk-based and scientific-based quality system to support Good Pharmacovigilance Practice (GVP).Establish and maintain… more
- Aequor (Athens, GA)
- …others, continuously raises the bar. Five (5) to seven (7) years of quality assurance experience in the pharmaceutical industry providing oversight to ... Responsible for executing QA operations and overseeing junior team members as...critical issues within area assigned and may escalate to senior management team based on severity of the issue.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …approvals. Lead in a proactive and strategic way and through collaboration with other GxP Quality representatives, act as QA point person for all GxP matters for ... the Global Program Head and the Global Program Team. Provide operational QA leadership for the respective GPTs, including Quality Oversight for the Quality … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …final drug product, QA shop floor oversight of manufacturing operations, Quality Assurance review and approval functions, and QC laboratory oversight, among ... of multiple myeloma. Legend Biotech is seeking a Director, QA Operations as part of the Quality ...experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality… more
- Merck & Co. (North Wales, PA)
- …and providing tools and templates to support delivery focusing on traceability, quality assurance , data conformance and data fitness. The position is ... Job DescriptionThe Senior Statistical Programmer, Study Data Tabulation Model (SDTM),...with key stakeholders.Solid project management skillsDemonstrated success in the assurance of deliverable quality and process compliance.Familiarity… more
- Merck & Co. (North Wales, PA)
- …years prior experience in the Pharmaceutical/Biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control ... Job DescriptionThe Senior Specialist, Quality Management Systems and Compliance reports to the Director, Animal Health Quality Management Systems and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …teams, and supports change implementation. Coordinates with regional/global RACMC, Quality Assurance , Pharmaceutical Technology, and other functional areas ... that CMC documentation is complete, well organized, scientifically sound, of a high quality , aligned with the current regulations, and presented in a manner that… more
- Insmed Incorporated (Bridgewater, NJ)
- …to the transition of the TMF to Insmed at end of study. Partner with Quality Assurance team to help clinical study team with audits/inspections for CRO/vendors ... with collaborating with CROs and third‐party vendors to ensure successful and quality execution of studies, and builds strong working relationships to create strong… more
- Catalent (Harman, WV)
- …biologic, pharmaceutical or medical device industry performing direct hands-on work in a Quality Assurance / Quality Control function with a strong familiarity ... raw materials release, and compiling, trending and reporting key quality metrics for Senior Management review, and...supervisionAbility to work in fast paced environment supporting the quality assurance / quality control departments of… more
- Tris Pharma (Monmouth Junction, NJ)
- …Summary:The Manager, Quality Management Systems (QMS) supports, oversees and manages the Quality Assurance ( QA ) Investigations and Product Quality ... and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior Leadership,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe Vice President, Quality Assurance will serve as an in-house subject matter expert on GxP compliance. He/she will also serve as key ... customer-facing senior quality leader to ensure the full...Design and implement programs, policies, and practices to ensure Quality Assurance and GxP compliance, and lead… more
- Novo Nordisk Inc. (Boulder, CO)
- …Chemical Development, Analytical Services, Engineering, Facilities, EH&S, Program Management and Quality Assurance . The Technical Team Lead, API Manufacturing ... to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our… more
- Eisai, Inc (NJ)
- …provider business relationships in alignment with global strategies.Review and approve Clinical Quality Assurance audit plans and reports.Review and respond to ... skills.Highly analytical with an attention to detail.Able to influence senior key stakeholders and build relationships between different functions.Capable of… more
- Merck & Co. (North Wales, PA)
- …experience in clinical research (eg, monitoring, data management, clinical quality assurance , study management)Experience with risk management tools ... It is business critical that our company receives consistent, accurate, high- quality data from clinical trials conducted worldwide. REAIM ( Risk Evaluation… more
- Merck & Co. (Rahway, NJ)
- …efficient solutions.Define and enforce coding standards, development methodologies, and quality assurance processes.Drive innovation in SAP development ... and technologies.- They will lead the Technology Integration Meeting and provide Senior Technology approvals in the Design Authority.- They will ensure the smooth… more
- Merck & Co. (North Wales, PA)
- …Strong listening skills.Demonstrated sound understanding of related fields (eg, manufacturing, analytical, quality assurance ) and the ability to be creative and ... Job DescriptionUnder general supervision of an Executive Director/ Senior Director, the Principal Scientist /Director is responsible for developing and implementing… more
